1. Field of the Invention
The subject invention relates to a focused energy blood withdrawal and analysis system.
Further, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which permits microscopic openings or holes to be formed into the epidermal layer of a patient in a substantially rapid manner with a minimization of dermal nerve stimulation.
Still further, the subject invention directs itself to a blood withdrawal and analysis system wherein the major components are located within a hand-held portable housing and transmit parameters being measured to an external display.
The subject invention relates to a non-invasive focused energy blood withdrawal and analysis system. In particular, the present invention directs itself to a hand-held, portable system for creating microscopic incisions in an epidermal layer. More particularly, this invention is directed towards a system for drawing blood from the incision and analyzing the drawn blood sample for various blood components. More particularly, this invention directs itself to a blood withdrawal system using a focused energy beam to incise the epidermal layer.
Further, the hand-held system has a vacuum pump mounted within the portable housing in order to draw a blood sample from the incision in the epidermal layer. Additionally, this invention directs itself to a blood analysis system having sensor elements mounted within the housing for substantially instantaneous analysis of the blood sample.
Still further, this invention is directed to a non-invasive focused energy blood withdrawal and analysis system which includes an energy source located within the housing for generating an energy beam with the energy beam being focused on an epidermal layer to create a microscopic opening in the epidermal layer.
Still further, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which includes a logic processing unit coupled to an energy source, all of which are mounted within a housing.
Additionally, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which combines a vacuum pump, a logic processing unit, and an energy source within a housing which is portable in nature and adapted to be hand-held.
Further, the subject invention pertains to a non-invasive focused energy blood withdrawal and analysis system which includes an energy source, a vacuum pump, and a slide located in the fluid path of a blood sample withdrawn from an epidermal layer upon actuation of the energy source under control of the logic processing unit.
Additionally, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which includes a display for displaying parameters of blood withdrawn through the epidermal layer where the display is coupled to a logic processing unit and a power source.
More in particular, this invention is directed to a non-invasive focused energy blood withdrawal and analysis system where a slide for collecting blood being drawn from an epidermal layer is removably mounted within a housing and is placed in the fluid path of the blood sample being drawn by a vacuum pump mounted within the housing.
Still further, the subject invention relates to a non-invasive focused energy blood withdrawal and analysis system which provides for a pulsed energy wave, delivered in a repeated programmed manner, in order to precisely control the diameter of an opening or hole to be made in the skin and further to control the depth of the hole being generated.
Further this invention provides for a non-invasive focused energy blood withdrawal and analysis system where focused energy in the form of a laser, a sonic beam or an electrical current is used to incise an epidermal layer whereby the focused layer transmission components are located in a portable housing.
2. Prior Art
Blood withdrawal and analysis systems are known in the art. In general, such prior art systems include some type of focused energy for incising the epidermal layer. In many instances, however, the blood to be analyzed flows through the incision of the epidermal layer under the body""s own blood pressure which is a slow and inefficient process. Further, prior art analysis systems often draw the blood sample within permanent analysis chamber. Not only is the preparation of a special chamber time consuming and generally inefficient, but it is also relatively unsanitary. It is a purpose of the subject invention to provide a combination of elements making up a hand-held, portable blood withdrawal and analysis system which allows for the use of both a focused energy beam to incise an epidermal layer, and an adjustable vacuum pump for applying variable suction to the incision on the epidermis. Further, the subject invention provides a removable dry slide positioned in the flow of the blood sample for collecting the blood sample for analysis. The removable slide is replaceable within the housing subsequent to a particular test being completed.
One such prior art withdrawal and analysis system is shown in U.S. Pat. No. 5,617,851. This reference is directed to an ultrasonic transdermal system for withdrawing fluid from an organism and determining the concentration of a substance in the fluid. This system includes an ultrasonic transducer for generating pulses to be focused onto the skin of an organism. The trauma of the ultrasonic pulse causes the dermal-epidermal junction membrane and the capillary endothelial joints to open, allowing blood to be drawn. Substances to be detected in the blood are sensed by a substance sensing transducer, the output of the transducer being analyzed by a test data processor. This system does not include an additional vacuum pump for drawing the blood from the incision made in the skin.
Another such prior art blood withdrawal system is shown in U.S. Pat. No. 5,131,403. This reference is directed to a method for obtaining blood using iontrophoresis. This system uses electric current to penetrate the epidermal layer of a patient. The system, however, does not include an adjustable vacuum for aiding in the drawing of blood through the microscopic puncture in the skin.
U.S. Pat. No. 5,989,409 shows a prior art system directed to a method for glucose sensing. This system includes a plurality of electrodes for generating an electrical current to be sent through the skin of a patient, thereby drawing molecules, including glucose, through the patient""s skin and into a hydrogel patch. This reference does not include sensor elements allowing for the sensing of a variety of chemical compounds in blood, nor does it include a vacuum pump for expeditiously drawing blood through the skin.
U.S. Pat. No. 5,954,685 shows a prior art system directed to an electrochemical sensor with a dual purpose electrode. This system utilizes a pair of electrodes to generate an electrical current in a subject""s skin. Blood is thus drawn through the skin and collected for analysis in a reservoir system. The system, however, does not include a vacuum pump for aiding in the drawing of the blood through the skin.
Another prior art blood withdrawal system is shown in U.S. Pat. No. 5,895,362. This reference is directed to transdermal transport using ultrasonic standing waves. The system utilizes a sonic generator for generating an ultrasonic standing wave of a given frequency and distributing the wave over the surface of the skin. The system does not use a focused energy beam for incising of the skin, nor does it include a vacuum pump for aiding in the drawing of the blood from the epidermal layer.
None of the prior art provides for a combination of elements forming a blood analysis and withdrawal system which is hand-held, portable, includes a focused energy beam for creating a microscopic incision in the epidermal layer coupled with a vacuum pump for aiding in the drawing of the blood to be analyzed through the incision. Additionally, none of the prior art Patents provide for a removable slide to be positioned in the path of the blood sample flow within the analysis device, thus allowing for removable, sanitary analysis of the blood.
In prior art technology, various parameters have been analyzed by numerous techniques. In particular, in order to measure blood glucose, prior art techniques form an approximately 1 cm opening in the stratum corneum using perhaps some energy source such as lasers, ultrasound, or electrical current. Diffusion allows the fluid, with hydrostatic pressures approximating 0-2.0 mm Hg, to come to the surface of the skin. The amount of interstitial fluid for extraction is generally sparse in the epidermis in comparison to the dermo/epidermal layer.
In some prior art systems, suction has been used to expedite the extraction of fluid from the interstitial layers of the epidermis. However, disadvantageously, the high pressure created by the suction has been found to be painful and has led to bruising which is generally aesthetically unacceptable.
In particular, such prior art systems have disadvantageous effects, especially in the case of diabetic patients who have many tests taken over short time intervals. Numerous areas of bruising have been known to occur over the body.
Additionally, other prior art systems disclose the extracting of interstitial fluid from the superficial layers of the epidermis where the interstitial fluid is sparse. Due to the low hydrostatic pressure and the thinly dispersed interstitial fluid, the process is relatively slow. In such prior art techniques, it may take between 10 and 20 minutes to extract a single drop of the interstitial fluid. Such delays in time to measure blood glucose generally makes such a prior technique unattractive since insulin acts within 5 minutes and peaks in 20 minutes. Thus, glucose measurement in particular should be completed within 1-2 minutes and will result in a more efficient control of blood sugar to avert complications seen in diabetic patients.
The present invention provides for a non-invasive blood withdrawal and analysis system. The blood withdrawal and analysis system includes an energy source for creating a focused energy beam and a vacuum pump, both mounted within a portable hand-held housing. The system is placed against a patient""s epidermal layer and the focused energy beam is used to create a microscopic incision in the epidermis. The vacuum pump aids in drawing blood from the incision through a disposable suction tube. A removable dry slide is positioned in the path of the blood sample drawn from the incision in the epidermis. Sensor elements are mounted on either side of the dry slide, within the housing, for instantaneous analysis of the blood sample. Both the disposable suction tube and the dry slide may be removed and replaced for sanitary reasons.
It is a principal objective of the subject non-invasive blood analysis and withdrawal system to provide a portable, hand-held system for the withdrawal and analysis of a blood sample.
It is a further objective of the subject blood analysis and withdrawal system to provide a focused energy beam for creating a microscopic incision in an epidermal layer.
It is a further objective of the subject invention to provide an adjustable vacuum pump for aiding in drawing of blood through the microscopic incision formed in the epidermal layer.
It is a further objective of the subject invention concept to provide a blood analysis and withdrawal system having a removable dry slide placed in the path of the blood sample flow for collecting the blood sample to be analyzed.
It is a further objective of the subject invention to provide for sensor elements mounted on either side of the dry slide for instantaneous analysis of the blood sample.
It is an important objective of the present invention to provide a blood analysis and withdrawal system having a disposable suction tube for drawing blood through a microscopic incision in the epidermis combined with a removable dry slide positioned in the flow of the blood sample, both the disposable suction tube and the dry slide being removable and replaceable for sanitary reasons.